NCT03180359

Vaccines Immunogenicity in Renal, Hepatic, Cardiac or Pulmonary Transplanted Children

Vaccines Immunogenicity in Children Transplanted or Candidate for a Renal, Hepatic, Cardiac or Pulmonary Transplantation, Followed in the Rhône-Alpes Region. A Descriptive and Prospective Monocentric Cohort Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

Thanks to improved surgical techniques, postoperative management and immunosuppressive therapies, an increasing number of children benefit from renal, hepatic, cardiac and pulmonary transplantation. Infection is a significant cause of mortality and morbidity in these patients, particularly due to vaccine-preventable diseases. Vaccination is one of the effective means of reducing infection-related mortality in these particularly vulnerable children. It is mostly well-tolerated, but all the more effective as it is performed early before transplantation, at best during a dedicated consultation, according to a vaccine scheme adapted to the immunocompromised child. In the almost constant absence of clinical efficacy data in populations of immunocompromised individuals, vaccine efficacy is most often indirectly estimated by immunogenicity, using protective correlates obtained by extrapolation in immunocompetent individuals. Primary objective: To estimate the immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation, using serological titers measurements before and after a vaccine injection for: influenza, pneumococcus, chicken pox, measles, tetanus, hepatitis A and hepatitis B. These serological titers will be compared to correlates of protection existing for each valency. The evolution of serological titers will be described during the first year. The vaccination will be carried out within the routine care, according to the recommendations. Secondary objectives: * describe and quantify the vaccination status of patients * describe the vaccination coverage of their entourage * evaluate the tolerance and efficacy of vaccines

Conditions

• Transplantation

Interventions

Type	Name	Description
BIOLOGICAL	Recommended vaccine scheme according to French Vaccine Schedule 2015	* BCG * Measles mumps rubella (MMR) * Varicella (chicken pox) * Rotavirus * Seasonal flu (live vaccine delivered nasally and inactivated vaccine injectable) * Yellow Fever * Diphteria tetanus poliomyelitis whopping cough (DTwP) * Haemophilus influenzae type b * Hepatitis B * Meningococcus conjugate * Pneumococcus * Human papillomavirus * Hepatitis A Vaccine administration would be done according to French Vaccine Schedule 2015 for mainstream population and for grafted children or transplant candidate children

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-10-13
• Completion: 2019-10-13
• First posted: 2017-06-08
• Last updated: 2023-03-08

Locations

1 site across 1 country: France